A new policy initiative recently agreed between the Hong Kong and China Mainland governments proposes to allow Hong Kong-listed medical devices and drugs to be sold to Hong Kong-owned medical institutions within the Greater Bay Area without prior NMPA registration.
The Chinese Government is pushing to develop the Greater Bay Area, also known as the Pearl River Delta, which includes the cities Guangdong, Hong Kong, Shenzhen and Macau and has a population of 73 million which, to put in perspective, is nearly the size of Germany.
The policy focuses on the following areas：
1. The use of clinically urgent drugs by designated medical institutions opened in 9 cities in the Area, which have been listed in Hong Kong and Macao, shall be approved by the Guangdong Provincial Government authorized by the State Council.
1.1 Scope of implementation:
The use of clinically urgent medical devices by designated medical institutions opened in 9 cities in the Area, which were purchased and used by public hospitals in Hong Kong and Macao, with advanced clinical applications, shall be approved by the Guangdong Provincial Government.
1.2 Implementation procedures
Import approval: Designated medical institution submits an application for clinical drug use and Guangdong Provincial Health Commission will confirm if it is a clinical emergency. If requirements are met, the designated medical institution shall submit the import application to the Guangdong Food and Drug Administration. According to the review opinions, approval license shall be issued by Guangdong Provincial Food and Drug Administration.
Customs Declaration: Designated medical institutions shall apply to the Food and Drug Administration of Mainland Ports in the Guangdong-Hong Kong-Macao Greater Bay Area for the Import Drug Clearance Form with the approval license. The customs shall handle the customs clearance procedures in accordance with the provisions. The designated medical institutions, then, entrust drug distributors to purchase, import and distribute drugs according to regulations.
2. Suspension of the clause of statute implementation: Article 11, paragraph 2, of the Regulations on the Supervision and Administration of Medical Devices has been suspended in 9 cities in the Area.
2.1 Designated medical institutions: The main body of medical and health service providers in Hong Kong and Macao was established by sole proprietorship, joint venture or cooperation in the Area, which is audited and confirmed by the Guangdong Provincial Health and Health Commission.
2.2 Imported medical device catalog: Medical devices, which public hospitals in Hong Kong and Macao have purchased and used, belong to the clinically urgent need, with advanced clinical applications, the imported medical device catalog shall be determined by the Guangdong Provincial Health Commission, the NMPA and in cooperation with the health departments in Hong Kong and Macao in accordance with clinical needs, and implement dynamic adjustment.
2.3 Import approval:
(i) Designated medical institutions: Apply for the use of medical device;
(ii) Guangdong Provincial Health Commission: Assess clinical needs and issue audit opinions;
(iii) The Guangdong Provincial Drug Administration: Evaluates the advancement of clinical applications and issues import approval opinions;
(iv) The Guangdong Provincial Department of Commerce: Issue import audit opinions if medical devices belonging to large-scale medical equipment in accordance with relevant regulations.
- 2.4 Customs clearance management:
- (i) Designated medical institutions: Apply for medical device import customs clearance;
- (ii) Guangdong Customs: Inspect and release in accordance with the provisions;
- (iii) Medical device operators: Purchase, import and distribute medical devices in accordance with the provisions.
3. Speed up the construction of the Greater Bay Area Divisional Center for Drug and Medical Device Review and Inspection by the State Drug Administration.
4. Support the development of Chinese medicine industry in Hengqin- Hong Kong-Macao Chinese Medicine Science and Technology Industrial Park.
5. Carry out the reform of drug market license holders and medical device registrars in the Area.
6. Set up a drug import port in Zhongshan City.
Regulatory Innovation and Development Work Programme for Drug and Medical device in Guangdong, Hong Kong, Macao and the Greater Bay Area